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S0216, Combination Chemotherapy and RT in Treating Patients With Stage III or Stage IV Head and Neck Cancer

21. juli 2011 oppdatert av: Southwest Oncology Group

Docetaxel (NSC-628503), Cisplatin (NSC-119875), And 5-Fluorouracil (NSC-19893) Induction Chemotherapy Followed By Accelerated Fractionation/Concomitant Boost Radiation And Concurrent Single Agent Cisplatin (NSC-119875), In Patients With Advanced Squamous Cell Head And Neck Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients with stage III or stage IV head and neck cancer.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

  • Determine the overall survival of patients with stage III or IV squamous cell head and neck cancer treated with docetaxel, cisplatin, and fluorouracil followed by accelerated fractionation/concomitant boost radiotherapy and cisplatin.
  • Determine the unconfirmed complete response rate in these patients after treatment with induction chemotherapy.
  • Determine the overall complete response rate (confirmed and unconfirmed) in patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.

OUTLINE:

  • Induction Chemotherapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 30-60 minutes on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity.
  • Chemoradiotherapy: Beginning within 3-4 weeks after administration of the second course of induction chemotherapy, patients receive accelerated fractionation radiotherapy once daily, 5 days per week, for 6 weeks with concomitant boost radiotherapy once daily, 5 days a week, for the last 2.5 weeks of radiotherapy. Patients also receive concurrent cisplatin IV over 30-60 minutes on days 1 and 22.

Patients are followed every 2 months for 1 year, every 3 months for 2 years, every 4 months for 1 year, and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.

Studietype

Intervensjonell

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35294-3300
        • University of Alabama at Birmingham Comprehensive Cancer Center
      • Mobile, Alabama, Forente stater, 36607
        • MBCCOP - Gulf Coast
    • Arizona
      • Phoenix, Arizona, Forente stater, 85006-2726
        • CCOP - Western Regional, Arizona
      • Phoenix, Arizona, Forente stater, 85012
        • Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
      • Tucson, Arizona, Forente stater, 85723
        • Veterans Affairs Medical Center - Tucson
      • Tucson, Arizona, Forente stater, 85724
        • Arizona Cancer Center at University of Arizona Health Sciences Center
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, Forente stater, 72205
        • Veterans Affairs Medical Center - Little Rock (McClellan)
    • California
      • Duarte, California, Forente stater, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • Fresno, California, Forente stater, 93720
        • California Cancer Center
      • Los Angeles, California, Forente stater, 90033
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Martinez, California, Forente stater, 94553
        • Veterans Affairs Outpatient Clinic - Martinez
      • Oakland, California, Forente stater, 94609-3305
        • CCOP - Bay Area Tumor Institute
      • Orange, California, Forente stater, 92868
        • Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
      • Sacramento, California, Forente stater, 95817
        • University of California Davis Cancer Center
      • Santa Rosa, California, Forente stater, 95403
        • CCOP - Santa Rosa Memorial Hospital
      • Travis Air Force Base, California, Forente stater, 94535
        • David Grant Medical Center
    • Colorado
      • Aurora, Colorado, Forente stater, 80010
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
      • Denver, Colorado, Forente stater, 80220
        • Veterans Affairs Medical Center - Denver
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20060
        • MBCCOP - Howard University Cancer Center
    • Florida
      • Tampa, Florida, Forente stater, 33612
        • Veterans Affairs Medical Center - Tampa (Haley)
    • Georgia
      • Atlanta, Georgia, Forente stater, 30342-1701
        • CCOP - Atlanta Regional
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96813
        • MBCCOP - Hawaii
    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • Veterans Affairs Medical Center - Chicago (Westside Hospital)
      • Chicago, Illinois, Forente stater, 60612
        • MBCCOP - University of Illinois at Chicago
      • Decatur, Illinois, Forente stater, 62526
        • CCOP - Central Illinois
      • Hines, Illinois, Forente stater, 60141
        • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
      • Maywood, Illinois, Forente stater, 60153-5500
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160-7353
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
      • Wichita, Kansas, Forente stater, 67214-3882
        • CCOP - Wichita
      • Wichita, Kansas, Forente stater, 67218
        • Veterans Affairs Medical Center - Wichita
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40502-2236
        • Veterans Affairs Medical Center - Lexington
      • Lexington, Kentucky, Forente stater, 40536-0084
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70112
        • Veterans Affairs Medical Center - New Orleans
      • New Orleans, Louisiana, Forente stater, 70112
        • MBCCOP - LSU Health Sciences Center
      • New Orleans, Louisiana, Forente stater, 70112
        • Tulane Cancer Center at Tulane University Hospital and Clinic
      • Shreveport, Louisiana, Forente stater, 71130-3932
        • Louisiana State University Health Sciences Center - Shreveport
      • Shreveport, Louisiana, Forente stater, 71101-4295
        • Veterans Affairs Medical Center - Shreveport
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02118
        • Cancer Research Center at Boston Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48105
        • Veterans Affairs Medical Center - Ann Arbor
      • Ann Arbor, Michigan, Forente stater, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Ann Arbor, Michigan, Forente stater, 48109-0912
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, Forente stater, 48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
      • Detroit, Michigan, Forente stater, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Detroit, Michigan, Forente stater, 48201-1932
        • Veterans Affairs Medical Center - Detroit
      • Grand Rapids, Michigan, Forente stater, 49503
        • CCOP - Grand Rapids
      • Royal Oak, Michigan, Forente stater, 48073-6769
        • CCOP - Beaumont
      • Southfield, Michigan, Forente stater, 48075
        • Providence Cancer Institute at Providence Hospital
    • Mississippi
      • Jackson, Mississippi, Forente stater, 39216-4505
        • University of Mississippi Medical Center
      • Jackson, Mississippi, Forente stater, 39216
        • Veterans Affairs Medical Center - Jackson
    • Missouri
      • Kansas City, Missouri, Forente stater, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, Forente stater, 63141
        • CCOP - St. Louis-Cape Girardeau
      • Saint Louis, Missouri, Forente stater, 63110
        • St. Louis University Hospital Cancer Center
      • Springfield, Missouri, Forente stater, 65807
        • CCOP - Cancer Research for the Ozarks
    • Montana
      • Billings, Montana, Forente stater, 59101
        • CCOP - Montana Cancer Consortium
    • New Jersey
      • East Orange, New Jersey, Forente stater, 07018-1095
        • Veterans Affairs Medical Center - East Orange
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87108-5138
        • Veterans Affairs Medical Center - Albuquerque
      • Albuquerque, New Mexico, Forente stater, 87131
        • MBCCOP - University of New Mexico HSC
    • New York
      • New York, New York, Forente stater, 10016
        • NYU School of Medicine's Kaplan Comprehensive Cancer Center
      • New York, New York, Forente stater, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University
      • Rochester, New York, Forente stater, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
    • North Carolina
      • Salisbury, North Carolina, Forente stater, 28144
        • Veterans Affairs Medical Center - Salisbury
      • Winston-Salem, North Carolina, Forente stater, 27104-4241
        • CCOP - Southeast Cancer Control Consortium
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45220-2288
        • Veterans Affairs Medical Center - Cincinnati
      • Cincinnati, Ohio, Forente stater, 45267-0501
        • Charles M. Barrett Cancer Center at University Hospital
      • Cleveland, Ohio, Forente stater, 44195-9001
        • Cleveland Clinic Taussig Cancer Center
      • Columbus, Ohio, Forente stater, 43206
        • CCOP - Columbus
      • Dayton, Ohio, Forente stater, 45429
        • CCOP - Dayton
      • Dayton, Ohio, Forente stater, 45428-1002
        • Veterans Affairs Medical Center - Dayton
    • Oregon
      • Portland, Oregon, Forente stater, 97207
        • Veterans Affairs Medical Center - Portland
      • Portland, Oregon, Forente stater, 97225
        • CCOP - Columbia River Oncology Program
      • Portland, Oregon, Forente stater, 97201-3098
        • Cancer Institute at Oregon Health and Science University
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Charleston, South Carolina, Forente stater, 29401-5799
        • Veterans Affairs Medical Center - Charleston
      • Greenville, South Carolina, Forente stater, 29615
        • CCOP - Greenville
      • Spartanburg, South Carolina, Forente stater, 29303
        • CCOP - Upstate Carolina
    • Tennessee
      • Memphis, Tennessee, Forente stater, 38104
        • University of Tennessee Cancer Institute
    • Texas
      • Amarillo, Texas, Forente stater, 79106
        • Harrington Cancer Center
      • Amarillo, Texas, Forente stater, 79106
        • Veterans Affairs Medical Center - Amarillo
      • Fort Sam Houston, Texas, Forente stater, 78234-6200
        • Brooke Army Medical Center
      • Galveston, Texas, Forente stater, 77555-0565
        • University of Texas Medical Branch
      • Houston, Texas, Forente stater, 77030
        • Veterans Affairs Medical Center - Houston
      • Houston, Texas, Forente stater, 77030-4095
        • University of Texas - MD Anderson Cancer Center
      • San Antonio, Texas, Forente stater, 78229-3900
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, Forente stater, 78229
        • Veterans Affairs Medical Center - San Antonio (Murphy)
      • Temple, Texas, Forente stater, 76504
        • Veterans Affairs Medical Center - Temple
      • Temple, Texas, Forente stater, 76508
        • CCOP - Scott and White Hospital
    • Utah
      • Salt Lake City, Utah, Forente stater, 84148
        • Veterans Affairs Medical Center - Salt Lake City
      • Salt Lake City, Utah, Forente stater, 84112-5550
        • Huntsman Cancer Institute
    • Washington
      • Seattle, Washington, Forente stater, 98101
        • CCOP - Virginia Mason Research Center
      • Seattle, Washington, Forente stater, 98108
        • Veterans Affairs Medical Center - Seattle
      • Seattle, Washington, Forente stater, 98109
        • Puget Sound Oncology Consortium
      • Tacoma, Washington, Forente stater, 98431-5000
        • Madigan Army Medical Center
      • Tacoma, Washington, Forente stater, 98405-0986
        • CCOP - Northwest

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma of the head and neck (excluding lip, nasopharynx, paranasal sinus, and salivary gland) by biopsy or fine needle aspirate of the primary lesion or neck mass

    • Stage III or IV disease

  • No evidence of distant metastases

    • Negative chest x-ray

  • Primary site in the head and neck region must be identified

    • No unknown primary site
  • Considered to be appropriate for definitive radiotherapy with curative intent

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic

  • Bilirubin no greater than upper limit of normal (ULN)
  • Alkaline phosphatase less than 2 times ULN
  • ALT or AST less than 1.5 times ULN

Renal

  • Creatinine less than 1.5 mg/dL

Cardiovascular

  • No myocardial infarction within the past 3 months
  • No unstable or uncontrolled angina

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
  • No evidence of pre-existing peripheral neuropathy
  • No active systemic infection
  • No history of hypersensitivity reaction to products containing polysorbate 80

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • No prior radiotherapy

Surgery

  • No prior surgery for head or neck cancer

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Southwest Oncology Group

Samarbeidspartnere

National Cancer Institute (NCI)

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2003

Primær fullføring (Faktiske)

1. november 2007

Datoer for studieregistrering

Først innsendt

5. februar 2003

Først innsendt som oppfylte QC-kriteriene

5. februar 2003

Først lagt ut (Anslag)

6. februar 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

25. juli 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. juli 2011

Sist bekreftet

1. juli 2011

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDR0000269781
  • U10CA032102 (U.S. NIH-stipend/kontrakt)
  • S0216 (Annen identifikator: SWOG)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på docetaksel

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Uzbekistan

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

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